Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Average Daily Step Counts while on M6 (cardiac surgery general floor.)
研究概览
简要总结
Ambulation following surgery has been found to be beneficial for patients; however, nurses and doctors struggle with getting post-operative, hospitalized patients to walk on their own. One promising strategy to address this might be an ambulation orderly, an employee whose single responsibility is to assure that patients walk 3-4 times per day. However, the effect of the ambulation orderly on post-operative physical activity has not yet been described. It is important to quantify what the ambulation orderly does in order to assess if this is an effective method for helping patients walk. As a result, the investigators will perform a pilot randomized controlled trial to test the effects of an ambulation orderly in patients hospitalized with recent cardiac surgery. Half of the patients will be assigned to walk with the ambulation orderly 3-4 times/day and the control group will be given standard nursing encouragement and assistance and encouragement to walk. The investigators will evaluate the average total daily step counts (over the hospital course, usually 4-7 days) and the change in walking distance between a baseline and a final 6 minute walk test. The investigators will also evaluate exercise physiologic parameters (heart rate, oxygen saturation) during ambulation, patient functional independence, and patient satisfaction.
详细描述
The investigators will perform a prospective randomized controlled trial at Baystate Medical Center, a 684-bed academic teaching hospital that serves as the referral center for a population of approximately 800,000 people living in Western Massachusetts.
The responsibility of the ambulation orderly is to walk patients after having a cardiac surgery, such as a coronary artery bypass surgery or a valve replacement or repair. Patients will be randomized to receive visits from the ambulation orderly (ambulation group) or to receive the standard care of Baystate Medical Center (control group). The standard of care will be nurse-directed ambulation, as is currently done in all other nursing floors at Baystate Medical Center. Nurses will be instructed to walk with the patients as they did before the initiation of the ambulation orderly and as they do when the orderly is on vacation, at conferences, training, or away for illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have had a cardiac surgery procedure (coronary artery bypass grafting surgery or valve surgery). Must be ambulatory prior to surgery
排除标准
- •Unable to consent, cognitively impaired, and patients unable to walk prior to surgery
研究组 & 干预措施
Ambulation Orderly Intervention
Patients that are in this group are those randomized to receive visits from the ambulation orderly (ambulation group). The patients in this group will receive the visits from the ambulation orderly in addition to the standard of care that occurs with the rest of the hospital and with the control group.
干预措施: Ambulation orderly (Procedure)
Control Group
This is for the patients who are randomized to receive the standard care of Baystate Medical Center. The standard of care will be nurse-directed ambulation, as is currently done in all other nursing floors at Baystate Medical Center. Nurses will be instructed to walk with the patients as they did before the initiation of the ambulation orderly and as they do when the orderly is on vacation, at conferences, training, or away for illness. These patients will not receive visits from the ambulation orderly.
结局指标
主要结局
Average Daily Step Counts while on M6 (cardiac surgery general floor.)
时间窗: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
The patient will wear an accelerometer, which will keep track of the amount of steps the patient took each day over the course of the hospitalization.
Average change in walking distance between baseline and final 6-minute walk
时间窗: From arrival on M6 (baseline) to hospital discharge (final). This is typically from post operative day 3 until post operative day 9-12
Each patient will complete a 6 minute walk after arriving on M6 (from intensive care until) and again at hospital discharge. The difference in distance walked will be compared.
次要结局
- Average Slope of Progression in Average Total Daily Step Counts(From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.)
- Average Daily Step Count on the 3rd day after arrival on M6(3rd day on M6 as part of study (typically post operative day 6 or 7))
- Average Total Daily Energy Expenditure(From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.)
- Average Total Time in Activity(From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.)
- Pre and post 6 minute walk test vital signs(Each time the 6 minute walk test is done.)
- Barthel Index(From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.)
- Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey(Following the hospital stay within 2-6 weeks)